NAPSR News: FDA Grants Amgen Priority Review For Ivabradine To Treat Chronic Heart Failure

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WASHINGTON - Aug. 28, 2014 - PRLog -- Amgen has received a priority review designation from the U.S. Food and Drug Administration (FDA) for ivabradine for the treatment of chronic heart failure (HF).  Ivabradine is an investigational oral drug inhibiting the sinoatrial node(cardiac pacemaker) and slows the heart rate without negative effects on myocardial contractility or ventricular repolarization.

"The priority review designation by the FDA is evidence that chronic heart failure is a serious condition, which leads to high rates of rehospitalization and poor prognosis despite available treatments. If approved, ivabradine would potentially provide a significant improvement, on top of standard-of-care therapies, for this grievous condition," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are excited about the opportunity to bring this important therapeutic option to certain patients with chronic heart failure in the U.S."

The priority review designation is normally allocated to drug applications to treat serious conditions and pending regulatory approval, improve safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies.  The priority review  for ivabradine was based on clinical trial data achieved from the Phase 3 SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) study assessing 6,500 patients in sinus rhythm with reduced left ventricular function and heart rate >70 beats per minute (bpm). The FDA also granted fast track designation for ivabradine for patients with chronic HF in April 2014. This designation is intended to accelerate the developmental and review process for drugs to treat serious conditions.

Heart failure affects approximately 26 million worldwide, including approximately 5.1 million people in the U.S. An estimated 50 percent of people diagnosed die within five years and it is projected that by 2030 HF will increase by 25 percent.

With such industry leaders paving the way with new beneficial therapeutic breakthroughs, they will need both certified and qualified individuals to promote their diversified product portfolio. When industry leaders look for new candidates for sales/marketing positions, they look toward individuals that are industry trained. Companies are looking for people that have the background to sell their product both proficiently and efficiently.

The CNPR is a federally trademarked certification you can earn by demonstrating the necessary knowledge in pharmacology, medical terminology, physiology, and regulations for selling pharmaceuticals. The CNPR examination is dedicated to increasing the professional level of NAPSR members and to developing meaningful and ethical standards fully accepted by both its members and members of the pharmaceutical community.

The CNPR® Program represents a level of industry achievement and a demonstrated knowledge of pharmacology, medical terminology, pharmaceutical selling guidelines, physician selling techniques and industry standards. Pharmaceutical sales candidates who have this training will differentiate themselves from other individuals looking for open positions. Upon successful completion of the training each student will receive the Certification Mark of the CNPR®. CNPR® graduates should immediately utilize the NAPSRx® Career Center to apply for pharmaceutical sales positions.

Individuals that are interested in becoming a Certified National Pharmaceutical Representative (CNPR) can contact the National Association of Pharmaceutical Sales Representatives(NAPSRx) for more information or visit the website at

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Tags:Napsr, Naprx, CNPR Certification Program, Pharmaceutical Sales, Napsrx
Industry:Biotech, Health
Location:Washington - District of Columbia - United States
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Aug 28, 2014 News

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